Body wall defects such as hernias and trocar punctures are typically repaired by implanting surgical mesh patch implants at the site of the body wall defect. The mesh patch implants are secured to the surrounding tissue in a conventional manner including tacking, suturing, gluing, etc. A surgical mesh implant is typically constructed to have one or more layers of a porous surgical mesh shaped to conform to the body wall defect in order to provide for optimal securement. The mesh implants must also be designed to promote sufficient tissue ingrowth such that the body wall defect repair is incorporated into the body wall tissue to provide superior strength and durability. Another desired attribute of a tissue repair implant is that it have softness and flexibility, along with minimal mass in order to provide the patient with the requisite post-operative comfort.
Since tissue repair implants are typically made from surgical meshes or fabrics that are flexible, the implants may present deployment issues to the surgeon during the course of a surgical repair procedure, when it is necessary to insert the mesh into a patient's body cavity and then appropriately affix the mesh implant to secure it in place in order to effect the repair of the tissue defect. Typically, the mesh in its relaxed configuration will be significantly larger than the size of the defect and the size of the opening in the patient through which the mesh is introduced. The mesh implant is usually folded or rolled by the surgeon in order to introduce it to a location adjacent to the tissue defect. It must be then unfolded or unrolled to its at-rest planar configuration to allow for fixation. The mesh repair implant must then be moved into place adjacent to the body wall so that it can be fixated in a conventional manner using tacks, sutures, etc. Those skilled in this art will appreciate the difficulties in moving and fixating a soft, low mass, flexible mesh implant during a surgical repair procedure. The difficulties are significantly enhanced in minimally invasive surgeries.
In order to improve the handling characteristics of mesh implants, devices have been developed that urge the mesh implant into a planar configuration after insertion into the patient's body. In the case of mesh implants for open procedures, elastic supports such as monofilament rings have been sewn into the mesh implants. However, it is known that these support structures may fail in vivo leading to life threatening complications and severe patient pain and discomfort. Instruments have also been developed to deliver tissue repair implants to a tissue defect site. The instruments typically have manipulatable fingers or members that maintain the mesh in a substantially planar position at the defect site; and, after the implant is affixed to the defect site the fingers or members are withdrawn into the delivery instrument and the instrument is removed. Such instruments also have disadvantages. The fingers or members may injure tissue or viscera causing a variety of complications, and the instruments may fail in use and not properly function to maintain the mesh implant in a planar position, or may fail to release the implant. In addition, the instruments are typically disposable, and, are expensive, thereby adding to the cost of the procedure.
In many open tissue defect procedures, it is necessary to utilize a skirted mesh device or a device having a pocket in order to provide an accessible structure for affixing the device securely to the inner wall of the body cavity (e.g., the peritoneum and fascia), since the surgeon is not able to affix the mesh from the visceral side of the device. In an endoscopic procedure, the surgeon can view the visceral side of the tissue repair patch remotely via an endoscopic camera system, and precisely guide a fixation instrument to fixate the device about the periphery and interior to the periphery in a multiple crown fixation pattern. In an open procedure this is typically not possible and the surgeon must guide the end of a fixation device by estimating the position of the periphery of the mesh device and by palpating the patient's skin to determine the location. This technique may have several deficiencies associated with it. As mentioned previously, in order to have an adequate repair with the best prospects for proper healing it is necessary to secure the mesh implant such that the mesh is placed as close and flush to the surface of the interior body wall as possible. If the mesh is not secured uniformly to body tissue about its periphery, the mesh may wrinkle or otherwise deform leaving sections of the mesh elevated above the surface of the body wall. This type of installation will not provide an optimal surgical or patient outcome, and revision surgery may be required. In addition, the spaces between the raised section of the mesh and the body cavity wall may be prone to surgical adhesions, infections, poor tissue integration, bowel entrapment, etc., further complicating the outcome for the patient.
There is a need in this art for novel adjunct devices that may be combined with a surgical tissue repair implant such that the device urges a tissue repair implant into a planar configuration for optimal surgical affixation, but is removable after the affixation is completed. There is a further need for such a device that has features which enable the surgeon to guide the end of an affixation instrument to properly locate fasteners about the periphery of the device.